Senior Technical Writer

Johnson & Johnson•Titusville, NJ

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. The Technical Writer is responsible for driving results in a fast-paced mutli-faceted environment by leading the technical writing of GMP documents and investigations associated within the NJ Stability Lab Operations. Assignments are of varying complexity, where sound judgement and self-drive/initiative are required to resolve problems and make recommendations/decisions. This position requires technical writing and investigations to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)

Requirements

Experience working in QC laboratory as a bench analyst
Demonstrated use of root cause analysis tools such as Kepner-Tregoe, Fishbone, 5-Why, etc.
Demonstrated written, verbal, and interpersonal communication skills with strong attention to detail
Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
Advanced technical writing skills
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
Ability to complete investigations including identification of root cause
Ability to work collaboratively and to lead and influence investigation team members to coordinate work based on priorities.
Experience with Quality Systems such as Trackwise, Docspace, TruVault or equivalent required
Able to communicate clearly at all levels of the organization required
Ability to work independently on assignments with minimal oversight required

Nice To Haves

Creativity is required regarding basic problem solving and troubleshooting in laboratory tasks.
The Technical Writer shall have the capability to develop improvement ideas and work within a team to implement associated solutions.
Possesses the ability to positively influence peers.
Positive and optimistic with the ability to act as a pro-active change agent.

Responsibilities

Provide project/study and investigation support through review and technical writing of GMP documents, SOPs and other documents associated within QC area of responsibility.
Uphold our Credo values including creating a positive work environment.
Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying assignable/root causes and determining effective corrective and preventative actions.
Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization.
Proofread documents for content and identify non-standard format or wording, and errors within documents.
Review data where required pertaining to documents being drafted
Participate in gap assessments of technical documentation to ensure methods are up to current standards, and that processes investigated are present and functioning optimally.
Provide recommendations/solutions to remediate any recognized gaps.
Present authorship strategy to management to get pre-approval and Endorsement.
Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval (Escalate any issue/delay to management as applicable).
Collect and trend historical data.
Responsible for preparing technical documentation for highly complex issues (i.e. high impact investigations).
Make contributions to improved processes and templates as it relates to laboratory investigations.
Provide training and mentorship for new investigation writers and lab analysts as it pertains to technical writing.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year